The present protocol describes a randomized, patient-blinded study in which either SmofKabiven emulsion for infusion or a hospital compounded "All in one" control Total Parenteral Nutrition (TPN) regimen will be given to adult surgical patients for 5 consecutive days. As serum prealbumin is a well-established surrogate efficacy parameter reflecting the patient´s nutritional status, the change of the serum prealbumin level at the day of the final study visit compared to baseline will represent the primary efficacy parameter in the present study.
In addition, other variables will be assessed in this study, i.e., postsurgical new onset of nosocomial infection, CRP, free fatty acids, immunology parameters, the results of physical examination, vital signs, relevant nutrition- and safety-related laboratory parameters in venous blood and urine, the results of an Electrocardiography (ECG), and the number, severity, seriousness, clinical relevance, relatedness and outcome of Adverse Events (AEs). The aim of the planned study is to demonstrate that SmofKabiven emulsion for infusion is not inferior to the comparative drug (hospital compounded "All in one" emulsion for parenteral nutrition).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
273
Total Parenteral Nutrition
Total Parenteral Nutrition
Beijing Friendship Hospital, Capital Medical University
Beijing, China
The Second Hospital of Jilin University
Changchun, China
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, China
Thepeople's hospital of Guangxi zhuang
Nanning, China
Shanghai First People's hospital
Shanghai, China
Shanghai Pudong Hospital
Shanghai, China
Zhongshan Hospital Fudan University
Shanghai, China
Shanxi Provincial People's Hospital
Taiyuan, China
Serum Prealbumin
Change in Serum Prealbumin
Time frame: 6 days
Nosocomial infection
Postsurgical new onset of nosocomial infection
Time frame: 6 days
Prealbumin
Change in Prealbumin
Time frame: 4 days
C-reactive Protein (CRP)
Change in CRP
Time frame: 6 days
Linoleic acid
Change in linoleic acid
Time frame: 6 days
Linolenic acid
Change in linolenic acid
Time frame: 6 days
Arachidonic acid
Change in arachidonic acid
Time frame: 6 days
Eicosapentaenoic acid (EPA)
Change in EPA
Time frame: 6 days
Docosahexaenoic acis (DHA)
Change in DHA
Time frame: 6 days
Thromboxane B3 (TX B3) / Thromboxane B2 (TX B2)
Change in TX B3/B2
Time frame: 6 days
Interleukin (IL)-1
Change in IL-1
Time frame: 6 days
Interleukin (IL)-2
Change in IL-2
Time frame: 6 days
Interleukin (IL)-6
Change in IL-6
Time frame: 6 days
Cluster of Differentiation 4 (CD4) / Cluster of Differentiation 8 (CD8)
Change in CD4/CD8
Time frame: 6 days
Plasma amino acid (taurine)
Change in taurine
Time frame: 6 days
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